HypothermiaNCT02742818

Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models

A study testing Upper body blanket, Bair Hugger and Underbody blanket, Bair Hugger in people with Hypothermia, run by Nelson Wolosker.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Prospective randomized trial comparing effectiveness of two different forced-air warming blankets in patients undergoing lower extremity angioplasty (LEA) and endovascular abdominal aortic aneurysm repair (EVAR). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypothermia
What is being tested?: Upper body blanket, Bair Hugger and Underbody blanket, Bair Hugger
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: No sites listed yet
Study dates: Sep 2014to Mar 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients undergoing LEA and EVAR
American Society of Anesthesiologists physical status (ASA) : 1-4

Who cannot join

Non-endovascular surgery
pregnant patients
patient refusal
less than 45 minutes duration of surgery

About this study

Read the detailed description

Fifty patients undergoing LEA and EVAR will be randomized into two groups: Group upper body blanket and Group underbody blanket. All patients will receive general anesthesia and body temperature will be measured and registered by an esophageal thermometer with 15 minutes interval beginning immediately after tracheal intubation up to tracheal extubation. The warming unit used (Bair Hugger 750 warming unit, Arizant Healthcare) will be the same for both groups and the blankets tested will be: upper body blanket (Bair Hugger 522 upper body blanket, 3M) and underbody blanket (Bair Hugger 635 full acess underbody blanket, 3M). Surgical and anesthetic complications will be noted. Only surgeries with minimum 45 minutes duration will be accepted for the purposes of this study.

Conditions: Hypothermia
Being tested: Upper body blanket, Bair Hugger, Underbody blanket, Bair Hugger
Keywords: forced-air warming, hypothermia, endovascular surgery, blanket
Medical subject headings: Hypothermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Upper body blanket, Bair HuggerDevice
Upper body warming blanket will be used in patients undergoing LEA and EVAR.
Underbody blanket, Bair HuggerDevice
Underbody warming blanket will be used in patients undergoing LEA and EVAR.

Study groups in NCT02742818
Study group	Role	What they receive
Upper body blanket, Bair Hugger	Other	Patients undergoing EVAR and LEA will use this type of warming blanket. Receives: Device: Upper body blanket, Bair Hugger
Underbody blanket, Bair Hugger	Other	Patients undergoing EVAR and LEA will use this type of warming blanket. Receives: Device: Underbody blanket, Bair Hugger

What is being measured

The primary outcome is the main question the study is designed to answer.

Values of Body Temperature ( in Celsius Degree ) in Two Groups of Patients Undergoing EVAR and LEA That Will Use Two Different Types of Bair Hugger 3M Body Warming Blankets, Namely: 522 Upper Body Blanket and 635 Full Access Underbody Blanket.
After tracheal intubation, upper body or underbody blanket will be turned on at the highest temperature of the warming unit ( 43 celsius degree) and the body temperatures will be measured and registered with an esophageal thermometer every 15 minutes until tracheal extubation. Temperatures will be compared with the purposes of determining which one of the two models tested are more effective in keeping patient warm. Values of body temperature across duration of surgery will be compared by models of variance analysis with repeated measurements. Duration of surgery will be used as a control variable.
Measured: Across duration of surgery (up to 210 minutes)

Secondary outcomes (4)

Age ( in Years)
The investigators will observe the profile of the patients and the mean of age in two groups.
Measured: At time of surgery ( in minutes)
Gender
The investigators will observe gender distribution in the two groups studied.
Measured: At time of surgery ( in minutes)
Type of Surgery ( LEA and EVAR )
The investigators will observe the type of surgery distribution profile in the two groups studied.
Measured: At time of surgery ( in minutes)
Duration of Surgery ( in Minutes)
The investigators will observe the duration of surgery (in minutes) in the two groups studied.
Measured: Across duration of surgery ( in minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Mar 2016

First posted19 Apr 2016 (estimated)
Study startSep 2014
Primary completionJun 2015
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypothermiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02742818
Sponsor's protocol ID: Forced-air warming in ES
Status last verified: Dec 2019
First submitted: 30 Mar 2016
Last updated: 30 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
Not yet recruiting
Hypothermic Oxygenated Machine PErfusion During Ex-vivo SPLITting in Liver Pediatric Transplantation (HOPESPLIT)
Pediatric Liver Transplantation

All Hypothermia trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models
ClinicalTrials.gov ID: NCT02742818
Acronym / sponsor ID: Forced-air warming in ES
Conditions: Hypothermia
Keywords: forced-air warming, hypothermia, endovascular surgery, blanket
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Nelson WoloskerUniversity, hospital or other
Study start: Sep 2014
Primary completion: Jun 2015 (actual)
Study completion: Mar 2016 (actual)
First posted: 19 Apr 2016 (estimated)
Results: Posted 23 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Upper body blanket, Bair Hugger	Other	Device: Upper body blanket, Bair HuggerPatients undergoing EVAR and LEA will use this type of warming blanket.
Underbody blanket, Bair Hugger	Other	Device: Underbody blanket, Bair HuggerPatients undergoing EVAR and LEA will use this type of warming blanket.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients undergoing LEA and EVAR
American Society of Anesthesiologists physical status (ASA) : 1-4

Key exclusion criteria (4 listed)

Non-endovascular surgery
pregnant patients
patient refusal
less than 45 minutes duration of surgery

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Upper body blanket, Bair HuggerUpper body warming blanket will be used in patients undergoing LEA and EVAR.	Device	Upper body blanket, Bair Hugger
Underbody blanket, Bair HuggerUnderbody warming blanket will be used in patients undergoing LEA and EVAR.	Device	Underbody blanket, Bair Hugger

Primary outcome

Values of Body Temperature ( in Celsius Degree ) in Two Groups of Patients Undergoing EVAR and LEA That Will Use Two Different Types of Bair Hugger 3M Body Warming Blankets, Namely: 522 Upper Body Blanket and 635 Full Access Underbody Blanket.
Time frame: Across duration of surgery (up to 210 minutes)
After tracheal intubation, upper body or underbody blanket will be turned on at the highest temperature of the warming unit ( 43 celsius degree) and the body temperatures will be measured and registered with an esophageal thermometer every 15 minutes until tracheal extubation. Temperatures will be compared with the purposes of determining which one of the two models tested are more effective in keeping patient warm. Values of body temperature across duration of surgery will be compared by models of variance analysis with repeated measurements. Duration of surgery will be used as a control variable.

4 secondary outcomes

Age ( in Years)
Time frame: At time of surgery ( in minutes)
Gender
Time frame: At time of surgery ( in minutes)
Type of Surgery ( LEA and EVAR )
Time frame: At time of surgery ( in minutes)
Duration of Surgery ( in Minutes)
Time frame: Across duration of surgery ( in minutes)

Results and safety

Results posted to the registry on 23 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Upper Body Blanket	25	25
Underbody Blanket	25	23

Primary outcome: Values of Body Temperature ( in Celsius Degree ) in Two Groups of Patients Undergoing EVAR and LEA That Will Use Two Different Types of Bair Hugger 3M Body Warming Blankets, Namely: 522 Upper Body Blanket and 635 Full Access Underbody Blanket.

Time frame: Across duration of surgery (up to 210 minutes). Median (Full Range). Unit: Celsius degrees

Measure	Upper Body Blanket n = 25	Underbody Blanket n = 23
Value	36.2 (35.1 to 37.3)	36.1 (34.3 to 37.1)

Upper Body Blanket vs Underbody Blanket: p = 0.190, Generalized Estimation Equations (GEE)

Population analysed: In the Underbody blanket group 2 patients were excluded from analysis. One of the patients due to anaphylactic reaction and the other framed exclusion criteria (Surgery time lesser than 45 minutes)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Upper Body Blanket	0 of 25 (0%)	0 of 25 (0%)	Not reported
Underbody Blanket	1 of 25 (4%)	1 of 25 (4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypothermia

Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
Not yet recruiting
Hypothermic Oxygenated Machine PErfusion During Ex-vivo SPLITting in Liver Pediatric Transplantation (HOPESPLIT)
Pediatric Liver Transplantation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Upper body blanket, Bair Hugger and Underbody blanket, Bair Hugger in people with Hypothermia, run by Nelson Wolosker.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Values of Body Temperature ( in Celsius Degree ) in Two Groups of Patients Undergoing EVAR and LEA That Will Use Two Different Types of Bair Hugger 3M Body Warming Blankets, Namely: 522 Upper Body Blanket and 635 Full Access Underbody Blanket. (time frame: Across duration of surgery (up to 210 minutes)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02742818.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019.